Safety and Efficacy of the Novel SpydrBlade Flex With Radiofrequency and Microwave Ablation Flexible Bipolar for Colorectal Endoscopic Submucosal Dissection - A Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- En-bloc resection rate
Study Overview
Brief Summary
This study is an interventional, prospective, single-center study to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for colorectal ESD in patients with superficial colorectal neoplasia.
Detailed Description
This is a prospective study with the following study Objectives:
- To evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for colorectal ESD.
- To assess the impact of the procedure on patient recovery time and postoperative adverse event.
This study is an interventional, prospective, single-center study to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for colorectal ESD in patients with superficial colorectal neoplasia. Patients will undergo a ESD for superficial colorectal neoplasia. All ESD procedures will be performed by expert endoscopists with at least 50 prior experience of ESD.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patient (age ≥18 and ≤80 years-old)
- •Capability of understanding and complying with the study requirements, including signing the informed consent form.
- •Patients with colorectal superficial mucosal neoplasia (clinically adenoma or early intramucosal cancer), scheduled to undergo endoscopic submucosal dissection (ESD).
Exclusion Criteria
- •Patients unable or unwilling to provide consent.
- •Patients with lesions unsuitable for ESD, including those suspicious of deep submucosal invasive cancer.
- •Patients with lesions involving the appendiceal orifice or ileocaecal valve.
- •Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake monitored anesthesia for the procedure.
- •Poor performance status (Eastern Cooperation Oncology Group performance status ≥3).
- •Pregnant women or those planning pregnancy or breastfeeding women.
- •Uncorrectable coagulopathy defined by international normalized ratio (INR) > 1.5 or platelet count < 50000/µl.
Arms & Interventions
Endoscopic submucosal dissection with SpydrBlade Flex
This group of patient would undergo endoscopic submucosal dissection with the use of the novel SpydrBlade Flex knife
Intervention: Colorectal ESD with SpydrBlade Flex (Device)
Outcomes
Primary Outcomes
En-bloc resection rate
Time Frame: 30 days
Defined by complete macroscopic resection of the target neoplasia in one single specimen
Secondary Outcomes
- R0 resection rate(30 days)
- Curative resection rate(30 days)
- Adverse event rate(30 days)
- Rate of adverse event - hemorrhage(30 days)
- Rate of adverse event - perforation(30 days)
- Rate of adverse event - post-ESD coagulation syndrome(30 days)
Investigators
Hon Chi Yip
Assistant Professor
Chinese University of Hong Kong